Ask the Experts: ICH E6 R2 Requirements

Q: ICH E6 R2 requires us to focus particularly on critical data and processes in quality risk management. Do you have any metrics that help assess whether our efforts are focused in this way? (Metric Insights Aug. 2021) 

A: This was a topic of discussion in the Centralized & Site Monitoring Process Metrics Work Group meetings earlier this year. Specifically, whether centralized monitoring is focused on critical data and processes. After much discussion, we included some metrics in the recently published Centralized & Site Monitoring Process Metrics Toolkit 1.0. They assess the proportion of risks/issues that are identified through centralized monitoring and any associated actions that are related to critical data and/or processes. We describe these as ‘aspirational’ metrics because those in the work group thought they would be very valuable to measure but that with current system configurations, it would not be possible to measure them. Without measuring in some way, how can we know whether our efforts are focused on these critical items or not? Our work groups include members from CROs and vendors, as well as sponsors, and are a great place to cross-fertilize ideas such as this. With vendors able to hear and take part in such discussions, it allows them to understand user perspectives and to prioritize items like these for development and inclusion in future releases.

Ask the Experts: Answers to your Metric Questions

With more organizations focusing on metrics, we have received an increase of questions ranging from how to use metrics, why some metrics are better than others, which type of metrics is best to use, as well as questions about specific metrics. This column provides a forum for us to share these questions and answers with you. Submit your question ›

Linda Sullivan

Senior Advisor, Metrics & Performance Management

WCG Avoca

Keith Dorricott

Metrics Subject Matter Expert

WCG Avoca